Merck’s Keytruda (pembrolizumab) Receives EC’s Approval in Combination with Trastuzumab as 1L Treatment for HER2-Positive Advanced Gastric Cancer
- The EC has approved Merck’s Keytruda (anti-PD-1 therapy) in combination with trastuzumab, fluoropyrimidine- and Pt-containing CT as 1L treatment of LA unresectable or metastatic HER2+ gastric or GEJ adenocarcinoma in adults whose tumors express PD-L1
- The approval was based on results from the P-III trial (KEYNOTE-811) evaluating Keytruda (200mg, q3w) + trastuzumab and CT vs trastuzumab and CT alone in 732 patients which showed significant improvement in PFS, & ORR, ≥80% of patients had tumors that were PD-L1+
- Trend toward improvement in OS in the ITT population but these results did not meet statistical significance per the pre-specified statistical analysis plan. The results will be presented at ESMO 2023
Ref: Merck | Image: Merck
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